Simulation of a backup circuit for pediatric parenteral nutrition, from prescription to administration

Context
Following the regulatory inspections, an activity continuity plan (ACP) was established to complete existing procedures in case of a scheduled or unexpected closure due to technical failure of the pediatric parenteral nutrition (PPN) compounding unit. This ACP consists of subcontracting the production of PPN to a specialized pharmaceutical establishment for the duration of the closure.

Objectives
To evaluate the operational readiness, safety, and efficiency of the backup circuit for PNN compounding, from prescription to administration.

Material and Methods
The conditions of the simulation exercise (SE) and quality indicators (QI) were defined in a multidisciplinary meeting between the pharmaceutical team and prescribing doctors (PD) of neonatology and pediatric intensive care units. The SE was planned to include the production of 10 PPN compounds for 10 patients : 8 standardized pediatric parenteral nutrition (sPPN) and 2 personalized pediatric parenteral nutrition (pPPN). The backup circuit, from prescription to administration, was simulated. QI were measured using an audit checklist and a satisfaction form. Results and areas for improvement were shared with PD and the subcontractor.

Results/Discussion
The main nonconformity identified during the audit was the subcontractor’s lack of operational readiness, as sPPN formulations had not been integrated into their production process despite prior validation. The SE was rescheduled following revalidation of sPPN formulations, with exclusion of pPPN due to pending stability validation, for 3 neonatology patients only. PD had access to a panel of 4 sPPN formulations with progressively increasing nutritional content: 2 binary admixtures with glucids and proteins and 2 ternary admixtures with lipids, glucids and proteins. To select the closest formulation to each patient’s nutritional needs, PD used an internal Excel-based tool. Three formulations were prescribed: 2 binary and 1 ternary. Prescription, ordering, and receipt of sPPN were compliant with the ACP, and all required quality controls were performed. Due to the 48 h delivery time, only 2 patients received sPPN, as the selected formulation for the third patient was no longer appropriate. Administration was properly documented in the medical records. Despite initial nonconformities, healthcare professionals involved in the SE were overall satisfied.

Conclusion
Although subcontracting PPN production is a reliable ACP, SE should be conducted regularly to ensure the subcontractor’s operational readiness, the efficiency of the hospital’s internal organization and coordination, and the ability to use the necessary tools. The production of pPPN within the ACP is challenging due to stability constraints and a high risk of unit conversion errors, which may compromise patient safety.

Key words: Parenteral nutrition; quality assurance; subcontracting process